Tyruko (natalizumab)
- Region
- 🇪🇺 EU
- Active substance
- natalizumab
- Company
- Sandoz GmbH
- Status
- Authorised
- Therapeutic area
- Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
- CHMP opinion
- Thu 20 Jul 2023
- EU approval
- Fri 22 Sep 2023
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/005752
- ATC
- L04AG03
- Official record
- www.ema.europa.eu
Indication
Tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods see sections 4.4 and 5.1) or Patients with rapidly evolving severe RRMS defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain Magnetic Resonance Imaging (MRI) or a significant increase in T2 lesion load as compared to a previous recent MRI.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Tysabri Authorised · Biogen Netherlands B.V.
- 🇪🇺 Natalizumab Elan Pharma Refused · Elan Pharma International Ltd.
Follow Tyruko
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.